ef5 in measuring tumor hypoxia in patients with stage i-iii non-small cell lung cancer

Conditions: Stage IA Non-Small Cell Lung Carcinoma; Stage IB Non-Small Cell Lung Carcinoma; Stage IIA Non-Small Cell Lung Carcinoma; Stage IIB Non-Small Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer

Summary: this pilot phase ii trial studies how well ef5 works in measuring lack of tumor oxygen, hypoxia, in patients with stage i-iii non-small cell lung cancer. ef5 may be effective in measuring the lack of oxygen in lung tumors and may allow doctors to plan better treatment.

primary objectives: i. assess the frequency and degree of hypoxia as measured by ef5 binding in patients with non-small cell lung cancer. ii. correlate hypoxia as measured by ef5 binding with potential serum/plasma markers of hypoxia in patients with non-small cell lung cancer. iii. correlate hypoxia as measured by ef5 binding with tissue markers of hypoxia in patients with non-small cell lung cancer. iv. correlate hypoxia as measured by ef5 binding with tumor angiogenesis in patients with non-small cell lung cancer. v. correlated hypoxia as measured by ef5 binding with apoptosis in patients with non-small cell lung cancer. vi. measure and characterize tumor perfusion in relationship to hypoxia in patients with non-small cell lung cancer. vii. correlate tumor perfusion to microvessel density in tumor samples in patients with non-small cell lung cancer. viii. determine the longevity of ef5 adducts in human lung tumors. outline: patients receive ef5 intravenously (iv) over 1-2.5 hours. beginning 24-55 hours later, patients undergo tumor hypoxia measurement using a polarographic needle electrode and intraoperative tumor measurement before undergoing surgical biopsy or resection. after completion of study treatment, patients are followed up for 4-6 weeks.

Eligibility criteria:
inclusion criteria: * known or suspected non-small cell lung cancer; patients without histologically or cytologically documented non-small cell lung cancer (nsclc) must be estimated by their physician to have at least 75% probability of having nsclc; the probability of malignancy will be predicted on the basis of known probabilities of individual clinical characteristics using a bayesian model * clinical or pathologic stage i to iii; patients in whom pre-surgical staging has not definitively establish stage iv disease are eligible * tumor mass at least 1.5 cm in maximum diameter must be present on computed tomography (ct) scan and must be included in the planned surgical biopsy or resection * patient must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy) and have the clinical and physiological status appropriate for this procedure * performance status 0-2 * bilirubin within normal limits * creatinine within normal limits or, if elevated, a creatinine clearance of at least 60 ml/min/m\^2 (ef5 is primarily excreted via the kidney) * white blood cell (wbc) \> 2000/mm\^3 * platelets \> 100,000/mm\^3 exclusion criteria: * pregnancy or breast feeding; a negative serum pregnancy test is required of any woman of childbearing potential prior to enrollment; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with ef5 * allergy to iv contrast dye * history of grade iii or iv peripheral neuropathy as defined by the national cancer institute (nci) common terminology criteria (ctc)